Effectiveness and Safety of a Clinical Assessment and 0h/1h Troponin Rule-Out Protocol
NCT03421873 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 16000
Last updated 2019-09-11
Summary
Chest pain is a common presenting complaint at the Emergency Department (ED). Many of these patients undergo lengthy assessments in the ED or are admitted which contributes to ED and hospital crowding as well as a substantial health care burden. The now commonly used high-sensitivity cardiac troponin assays enable faster rule-out of acute myocardial infarction (AMI). The European Society of Cardiology (ESC) recommend the use of a 0h/1h high-sensitivity cardiac troponin T (hs-cTnT) protocol, but all studies so far have been observational. The safety and effectiveness of the protocol when implemented in routine care is thus unknown.
The aim of this study is to determine the safety and effectiveness of the ESC 0h/1h hs-cTnT protocol, supplemented with clinical assessment and ECG, when implemented in routine care.
Conditions
- Chest Pain
- Acute Coronary Syndrome
- Myocardial Infarction
- Unstable Angina
Interventions
- OTHER
-
0h/1h hs-cTnT protocol
Implementation of a 0h/1h hs-cTnT protocol in routine care
Sponsors & Collaborators
-
Region Skane
collaborator OTHER -
Lund University
collaborator OTHER -
Ulf Ekelund
lead OTHER
Principal Investigators
-
Arash Mokhtari, MD, PhD · Lund University, Skåne University Hospital, Department of Internal and Emergency Medicine, Department of Cardiology, Lund, Sweden
-
Ulf Ekelund, MD, PhD · Lund University, Skåne University Hospital, Department of Internal and Emergency Medicine, Lund, Sweden
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2018-02-01
- Primary Completion
- 2018-12-30
- Completion
- 2018-12-30
Countries
- Sweden
Study Locations
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